Kornimate/medical-research-clean huggingface dataset:
latency and early neonatal provision of antiretroviral drugs clinical trial

Conditions: HIV

Summary: the investigators propose a non-randomized clinical trial of 60 hiv-infected infants identified within 48 hours of birth and their mothers to investigate the consequences of very early art on the establishment and maintenance of the viral reservoir. the first phase (early art initiation within 48 hours of birth) will examine the trajectory i.e. changes over time of the viral reservoir and detection of hiv-specific antibody responses in infants testing hiv-positive within 48 hours of birth and initiating early art. secondary pathogenesis aims will test whether markers of neonatal immune quiescence are associated with the extent of seeding and rate of decline of the viral reservoir when art is started at a young age and investigate whether markers in infant stool samples can be used as a non-invasive method of defining relevant immune and hiv-specific parameters associated with viral reservoir size. the investigators hypothesize that developmental characteristics of newborn immunity may make this period the optimal time to begin art and influence the seeding of the viral reservoir.

prevention of mother-to-child transmission (pmtct) programs using antiretrovirals (arvs) have had tremendous success in sub-saharan africa. however, hiv transmission continues to occur because (1) implementation of pmtct is incomplete and (2) arv interventions are not 100% effective in blocking infection. thus the challenge of providing treatment to hiv-infected children is far from over. the capacity of early art treatment to favorably influence the viral reservoir and potentially lead to post-treatment cessation viral control needs to be described in the population of infants, and to identify useful public health strategies.

Eligibility criteria:
inclusion criteria: * point of care (poc) or laboratory-based test positive on a sample collected within 48 hours of birth. * mother willing and able to provide informed consent. exclusion criteria: * expressed intention to leave the johannesburg area permanently. * co-morbidities, birth defects or other conditions which in the opinion of the clinical team have a greater than 50% risk of mortality in the first days of life. * co-morbidities or conditions which in the opinion of the clinical team advise against initiation of art within the first 48 hours of life. * active (uncontrolled) maternal psychiatric illness.

Keywords: hiv infant antiretroviral therapy, highly active antiretroviral agents
recombinant human keratinocyte growth factor in unrelated and related transplants

Conditions: Graft Versus Host Disease

Summary: this is a single arm dose escalation study of recombinant human keratinocyte growth factor given to patients undergoing allogeneic bone marrow transplantation who are at high risk for graft versus host disease (gvhd).

completion date provided represents the completion date of the grant per oopd records

Eligibility criteria:
eligible for full intensity bone marrow transplant (bmt) conditioning but who lack a 6/6 hla idential sibling donor

Keywords: graft versus host disease bone marrow transplant alternative donor
to assess the efficacy of over-the-counter analgesics in the prevention/treatment of transient post-dose symptoms following zoledronate infusion in post-menopausal women

Conditions: Osteopenia

Summary: zoledronic acid is a medicine being studied in people with low bone mass. side effects such as headache, fever, muscle aches, and pains, may occur following the infusion. this study will investigate the use of over-the-counter medicines to improve these symptoms.


Eligibility criteria:
inclusion criteria: * women greater than or equal to 45 years and less than or equal to 75 years of age inclusive * low bone mineral density exclusion criteria: * certain prior treatments for low bone mass/osteopenia * current use of medicines (prescription or non-prescription) for pain, fever, or inflammation * impaired kidney function other protocol-defined inclusion/exclusion criteria may apply.

Keywords: zoledronic acid bisphosphonate low bone mass
comparison of adr using nbi versus hd white light colonoscopy in screening and surveillance colonoscopies

Conditions: Narrow Band Imaging

Summary: the aim of this study is to compare adr using hd-nbi or hd-wle during screening and surveillance colonoscopies.

background: despite recent advances in endoscopic technology adenoma miss rate still is up to 20% and contributes to the occurrence of interval cancers. therefore, improved imaging modalities have been introduced to increase adenoma detection rate (adr) during screening and surveillance colonoscopies. recently, narrow band imaging (nbi; exera ii series, olympus corporation) was not significantly better than high definition white light colonoscopy (wlc) for the detection of patients with colorectal polyps, or colorectal adenomas1. however, olympus' current exera iii series is characterized by better illumination of the bowel lumen and may be associated with a higher adr than high definition wlc. methods: investigators performed a prospective evaluation in patients referred to the department of interdisciplinary endoscopy at jena university hospital for screening or surveillance colonoscopy between january and november 2015 in daily clinical practice. colonoscopy was performed by use of hd-wlc or hd-nbi upon withdrawal of the colonoscope (exera iii series, olympus corporation).

Eligibility criteria:
inclusion criteria: * screening colonoscopies exclusion criteria: * insufficient bowel cleansing * age under 55years

Keywords: adenoma detection rate narrow band imaging
fet in adenomyosis

Conditions: Adenomyosis

Summary: purpose of the study: to compare the effectiveness of gnrh agonist downregulation alone versus gnrh agonist combined with letrozole in improving pregnancy outcomes in women with adenomyosis undergoing frozen embryo transfer (fet). research question: is the combined use of gnrh agonist and letrozole more effective than gnrh agonist downregulation alone in achieving better ongoing pregnancy rates in adenomyosis cases undergoing fet? hypothesis: null hypothesis (h₀): the combined use of gnrh agonist and letrozole is not more effective than gnrh agonist downregulation alone in achieving a higher ongoing pregnancy rate in adenomyosis cases undergoing fet. study outcomes: primary outcome: ongoing pregnancy rate at 12 weeks of gestation.


Eligibility criteria:
inclusion criteria: diagnosis of adenomyosis confirmed via transvaginal ultrasound as per musa criteria history of infertility requiring frozen embryo transfer (fet). availability of at least one good-quality frozen embryo for transfer exclusion criteria: bmi ≥ 30 kg/m2 presence of endocrine disorders; (uncontrolled diabetes mellitus, / hyperprolactinemia, thyroid dysfunction, congenital adrenal hyperplasia, cushing syndrome, or polycystic ovary syndrome previous major uterine surgery gestational carrier fertility preservation

Keywords: frozen embryo transfer adenomyosis ongoing pregnancy rate live birth rate
thoracic injuries in pediatric polytraumatized patients: epidemiology, treatment and outcome

Conditions: Multiple Trauma

Summary: the present study predicts that concomitant chest injuries in polytraumatized pediatric patients are a potential source of substantial morbidity and mortality.


Eligibility criteria:
inclusion criteria: children with isolated, but severe and potentially life-threatening injuries iss ≥16 injuries to only one body cavity together with a single long bone fracture thoracic injuries exclusion criteria: injury severity score (iss) of \ 18 no thoracic injuries

Keywords: pediatric polytrauma thoracic injuries
a dose-ranging study of ati 7505 in patients with postprandial distress syndrome

Conditions: Post Prandial Distress Syndrome

Summary: to assess the efficacy of 3 oral dosing regimens of ati 7505 compared to placebo in patients with pds by comparing at the end of day 42 the percentage of patients in each treatment group who have had adequate relief of postprandial distress syndrome symptoms on at least 50% of the treatment days.


Eligibility criteria:
inclusion criteria: * were diagnosed with pds at least 6 months prior to screening, or had onset of 2 or more pds symptoms at least 6 months prior to screening. * experienced early satiety or bothersome postprandial fullness repeatedly during the 3 months prior to screening. * had a normal upper gi endoscopy within the past year. exclusion criteria: * heartburn that occurs \>3 times per week * current helicobacter pylori (h pylori) infection confirmed by stool sample testing or breath testing, or h pylori eradication therapy within the 6 months prior to screening * any alarm symptoms including uninvestigated anemia, rectal bleeding, weight loss, or unresolved fever within the 6 months prior to screening * at screening, a qt interval corrected for heart rate using bazett's correction formula (qtcb) \>440 msec as determined by the investigator.
a study to evaluate the efficacy of a counselling and advisory care for health (coach) program in dyslipidemic patients.

Conditions: Dyslipidemia

Summary: this study is a local pco sponsored, interventional, non-drug study to evaluate the efficacy of a health tele-counselling program in reducing cardiovascular risk in dyslipidemic patients.

educational / counseling

Eligibility criteria:
inclusion criteria: 1. subjects who are newly diagnosed with dyslipidemias. 2. subjects must be lipid drug naive and eligible for statin therapy. exclusion criteria: 1. subjects who cannot be contacted by telephone or handphone. 2. subjects with uncontrolled primary hypothyroidism.

Keywords: interventional non-drug disease management program cardiovascular risk control dyslipidemias primary care centers
evaluation of the safety and efficacy of rigid breathable scleral contact lenses for the correction of ametropia

Conditions: Ocular Surface Disease; Irregular Astigmatism; Contact Lens Complication; Corneal Astigmatism

Summary: to evaluate the short-term efficacy and safety of scleral contact lens in the clinical treatment of patients with irregular astigmatism after corneal transplantation by analyzing ocular parameters and ocular surface conditions of patients after corneal transplantation.


Eligibility criteria:
inclusion criteria: 1.8 ≤ age ≤ 55 years old;2.the diopter of one or both eyes is -25.00\~+25.00 d (including -25.00d and +25.00d), and corneal astigmatism caused by any reason (including keratoconus, irregular cornea) ≥0.75d. exclusion criteria: 1.patients who are judged by the investigator to be unsuitable for corneal endothelial cells;2.dry eye ;3.abnormal iop ;4.overt strabismus;5.bacterial, fungal, viral and other active corneal infections;6. being used may cause dry eyes or affect the eyeball or affect vision or affect the angle drugs such as membrane curvature;7.corneal sensory, active corneal lesions;8.conventional slit lamp microscopy and ophthalmoscopy, corneal diseases, iris cyclitis, chronic uveitis, cataract and vitreoretina related eye diseases disease or active and progressive disease;9.other eye diseases: such as dacryocystitis, eyelid diseases and eyelid abnormalities or infections, eye muscle-related diseases, optic pathway diseases, glaucoma;10.patients with systemic diseases that cause immunocompromise;history of allergy to contact lenses or contact lens care solution;11.history of allergy to contact lenses or contact lens care solution;12.pregnant, lactating or planning to become pregnant in the near future;13.subjects who are considered by the investigator to be unable to wear rigid contact lenses after comprehensively considering the corneal parameters, morphological characteristics and refractive examination results of the examination results;14.those who have worn hard contact lenses within 30 days or soft hydrophilic contact lenses within 10 days;15.those who participated in other drug clinical trials 3 months before screening and participated in other medical device clinical trials within 30 days;16.one-eyed patients;17.those who have a strong sense of foreign body and cannot tolerate it and have poor compliance, and cannot be timely and regular to the medical institution for medical treatment as required;18.other conditions judged by the investigator that the patient is not suitable for enrollment.

Keywords: ocular surface disease irregular astigmatism contact lens complication corneal astigmatism
high volume specialty knee replacement surgeons achieve better clinical and quality-of-life scores

Conditions: Total Knee Arthroplasty

Summary: to determine whether specialty training or high volume of operative experience is associated with better clinical outcome and quality-of-life scores.

primary total knee replacements are becoming a commonly performed procedure. many general orthopaedists can perform large numbers of such surgeries. thus, we aim to find out if there is value of having surgeons with ar fellowship training to perform primary total knee arthroplasty. this has an implication in the direction of the training of future ar surgeons and in the distribution of operative cases.

Eligibility criteria:
inclusion criteria: * patients who require total knee arthroplasty seen during the specified period exclusion criteria: * revision total knee arthroplasty * unicompartmental or bicompartmental knee arthroplasty

Keywords: outcome quality of life total knee arthroplasty clinical outcome scores post total knee arthroplasty quality of life scores post total knee arthroplasty
suprasacral parallel shift - ultrasound/mr image fusion guided lumbosacral plexus block

Conditions: Hip Fractures; Anesthesia Local; Pain, Perioperative

Summary: the main objective of the trial is to complete a double-blinded randomized controlled trial with crossover design of a lumbosacral plexus block with the suprasacral parallel shift technique guided by ultrasound/magnetic resonance (mr) image fusion vs. suprasacral parallel shift guided by ultrasound by estimating sensory block of the femoral nerve, the obturator nerve, the lumbosacral trunk, and spinal nerve l1 in healthy volunteers.

the main objective of the trial is to complete a double-blinded randomized controlled trial with crossover design of a one-injection nerve block of the lower part of the lumbar plexus and the upper part of the sacral plexus (suprasacral parallel shift, ssps) to achieve analgesia of the femoral nerve, the obturator nerve, the lumbosacral trunk, and spinal nerve l1 with ssps guided by ultrasound/mr image fusion vs. ssps guided by ultrasound by estimating sensory block of in healthy volunteers by estimating the sensory block of dermatomes of the terminal nerves in healthy volunteers. the secondary objective is to estimate a) preparation and b) procedure time, c) injection site and d) depth, e) discomfort, f) change in map, g) plasma lidocaine pharmacokinetics, h) motor and i) sensory block, j) perineural and k) epidural spread of lidocaine-epinephrine added gadotorate meglumine on mri, and l) cost-effectiveness of ssps guided by ultrasound/mr image fusion vs. ssps guided by ultrasound. the investigators hypothesize that block success is higher for ssps guided by ultrasound/mr image fusion than for ssps guided by ultrasound.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * volunteers who has given their written and oral informed consent to participate in the study after having fully understood the content and the limitations of the protocol. * normal healthy person (american society of anesthesiology \[asa\] classification i) exclusion criteria: * volunteers not able to cooperate in the study * volunteers not able to understand or speak danish * daily use of analgesics * allergy against the medicines used in the study * drug abuse (according to the investigator's judgement) * alcohol consumption greater than the recommendations of the danish national board of health * contraindication for mri including pregnancy * volunteer in whom nerve blocks are not possible due to technical reasons * volunteer who are incompetent (ie. surrogate consent is not accepted)

Keywords: hip surgery anesthesia perioperative analgesia
antiplatelet therapy in chronic urticaria

Conditions: Chronic Urticaria

Summary: this study compares the combination of antiplatelets and antihistamine versus antihistamine alone for the treatment of chronic spontaneous urticaria

this study is a randomized control trial comparing the effectiveness of the combination of antiplatelets and antihistamine and antihistamine alone for the treatment of chronic spontaneous urticaria

Eligibility criteria:
inclusion criteria: chronic spontaneous urticaria d-dimer levels over 500 ng/ml not respond to a conventional dose of antihistamine exclusion criteria: are taking aspirin have bleeding tendency have concurrent severe medical illnesses -

Keywords: chronic urticaria antiplatelet d-dimer
prevalence of oral manifestations of iron deficiency anemia in a sample of egyptian population

Conditions: Iron Deficiency Anemia

Summary: according to who reportin 2002, iron deficiency anemia was considered to be the most important contributing factor to the global burden of anemia. children and women in reproductive ages are more at risk factor for developing iron deficiency anemia.no previous study has been held to assess prevalence of oral manifestations of iron deficiency anemia as a hospital-based cross-sectional study on a sample of egyptian patients in hematology department (no previous data recorded).

study will be held in at the hematology department at el qasr al-einy cairo university hospital data collection started from february 2018 till end of april 2018 primary completion. clinical examination performed for oral mucosa, the number and type of lesions will be recorded. patients' age, sex, duration of illness, type of anemia, location of any oral lesion or abnormality, history of drug and alcohol consumption, and presence or absence of dentures, will be recorded participants will not followed up and data will be collected prospectively. a copy of participant's blood record will be obtained from the hematology department upon its approval. participants: egyptian patients diagnosed with iron deficiency anemia that attending the hematology department at el qasr al-einy cairo university hospital will be enrolled in the study. the age of participant enroll will be up to 70 years old, males and females will be included. for each eligible participant, a full history will be obtained according to an assessment sheet, followed by clinical examination which will be done through an interview between the investigator and the patient. all participants will be asked to sign a study-related informed consent. oral manifestations of these patients will be evaluated by an oral medicine master student (the investigator).

Eligibility criteria:
inclusion criteria 1. patients diagnosed with iron deficiency anemia based on their blood tests. 2. age: by maximum 70 years old. 3. males and females will be included. exclusion criteria 1. patients suffering from any other systemic diseases known to influence oral and maxillofacial manifestations will be excluded. 2. patients suffering from any other systemic diseases known to cause ida as secondary condition will be excluded. 3. patients on drug therapy that may have oral mucosal manifestations. 4. lesions appear because of existing local factors for example traumatic ulcer on the tongue because of sharp tooth against tongue, angular cheilitis because of poor denture design and older age patients. 5. inflammatory diseases, malignancy, or recent surgery were excluded.

Keywords: hemoglobin, iron, oral lesions, oral manifestations,cross-sectional study
app teaches doctors to diagnose skin cancer

Conditions: Melanoma (Skin); Carcinoma

Summary: this study aimed to examine if self-paced learning with a novel digital patient-case-based educational platform can increase primary care physicians' diagnostic accuracy of malignant and benign skin lesions on both the level of benign/malignant and the diagnosis level. secondarily the study aimed to investigate the time spent in reaching this change in proficiency.

participants were given a questionnaire and an initial skin cancer multiple choice-questionnaire (mcq) to test their diagnostic skills regardining skin and mole cancer and the most common differential diagnoses. participants in the intervention group was then given access to an educational mobile application (app) for 8 days and asked to diagnose 500 patient cases. the participants did so at their own leisure and time. after 8 days they were asked to abstain from using the app for another 8 days (wash out period) and were then given a final skin cancer multiple choice-questionnaire (mcq). participants of the control group received no intervention nor education during the 16 days of waiting before they took the final skin cancer multiple choice-questionnaire.

Eligibility criteria:
inclusion criteria: * primary care physician who works in general practice exclusion criteria: -

Keywords: digital learning e-learning melanoma carcinoma dermoscopy dermloop
st-segment elevation not associated with acute cardiac necrosis (lestonnac)

Conditions: STEMI - ST Elevation Myocardial Infarction

Summary: patients with chest pain and persistent st segment elevation (ste) may not have acute coronary occlusions or serum troponin curves suggestive of acute necrosis. our objective is the validation and cost-effectiveness analysis of a diagnostic model assisted by artificial intelligence (ai). our hypothesis is that an ai analysis of the surface electrocardiogram allows a better distinction of patients with ste due to acute myocardial ischemia, from those with another etiology. this is a prospective multicenter study with two groups of patients with ste: i) coronary arteries without significant lesions and without serum troponin curve suggestive of acute necrosis, ii) myocardial infarction with acute coronary occlusion. a manual centralized electrocardiographic analysis and another by ai algorithms will be performed.

this is a prospective multicenter study promoted by the ischemic heart disease and acute cardiovascular care section of the spanish society of cardiology. following institutional ethical approval, the surface ecg prior to the activation of the infarction code, and the ecgs before and after (up to a maximum of 20) the infarction code along with other clinical data will be collected across the different enrolled hospitals. sites will securely transfer the data to a centralized repository for processing. willem ai platform will automatically analyze the ecgs in parallel to an experienced observer. the results of the study will provide new information for the improvement in the stratification of patients with st segment elevation.

Eligibility criteria:
inclusion criteria: * age≥18 years. * chest pain or symptoms suggestive of myocardial ischemia. * ste at point j in the12-lead electrocardiogram prior to activation of the infarction code in two contiguous leads ≥0.1 mv, in v2 and v3 ≥0.2 mv. * signature of informed consent. exclusion criteria: * left bundle branch block. * acute cardiac necrosis in the absence of significant epicardial coronary artery stenosis \>70% (vasospasm, takotsubo stress cardiomyopathy, myocarditis, coronary artery dissection, acute myocardial infarction without obstructive coronary lesions - minoca). * ste≤0.1 mv with pathologic q wave suggestive of previous chronic infarction. * severe anemia (hemoglobin \<8.0 g/dl).

Keywords: st segment elevation artificial intelligence electrocardiogram acute myocardial infarction